MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI OCCIPITAL PLATE/ROD; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 498.956

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient age, dob & weight not provided for reporting.Additional product code: kwp unknown if device was explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device history records review was conducted.(b)(4).Manufacturing date: 18.Nov.2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that post-operative the cervifix occiput rod broke.The implantation was performed on (b)(6) 2016.No information available about patient condition, outcome or if a revision surgery was performed.This complaint involves 1 part.Concomitant reported parts: 5x locking cap (part and lot unknown); 5x pedicle screw (part and lot unknown); 1x rod (part and lot unknown); 1x locking screw axon (part 406.104 lot 9824135); 3x cortex screw (part and lot unknown); 3x cortex screw (part 404.310 lot 9401671, part 404.310 lot 3277548, part 404.312 lot 9789709).This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The doctor has not conducted a revision for the patient.

Manufacturer Narrative

Additional device product codes: used kwp, mnh, mni, kwq.(b)(4) used in the initial mw to capture additional medical/surgical intervention required.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI OCCIPITAL PLATE/ROD
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6329712
• MDR Text Key: 67387673
• Report Number: 1000562954-2017-10010
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819071339
• UDI-Public: (01)07611819071339(10)9728123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.956
• Device Lot Number: 9728123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/15/2017; 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1X LOCKING SCREW AXON PART 406.104, LOT 9824135); 3X CORTEX SCREW PART 404.310, LOT 3277548; 3X CORTEX SCREW PART 404.310, LOT 9401671,; 3X CORTEX SCREW PART 404.312, LOT 9789709); 3X CORTEX SCREW PART AND LOT UNKNOWN); 5X LOCKING CAP (PART AND LOT UNKNOWN); 5X LOCKING CAP PART AND LOT UNKNOWN); 5X PEDICLE SCREW PART AND LOT UNKNOWN)
• Patient Outcome(s): Required Intervention